IND FOIA

Investigational New Drug (IND) applications are not easily accessible, public information. At least for any candidate that goes into clinical trials, they should be, so that physicians and trial participants can review the scientific findings that make the basis for a therapeutic claim, and for accountability purposes post facto to make sure the manufacturer and the FDA have been doing due diligence in the event of a problem.

This should be challenged and the easiest mechanism to do this is via a FOIA request. As a test case, indysci.org will be issuing an FOIA against the SJG-136 IND application materials. I’ll report back the results here on the blog.